Robot-assisted IVOR-LEWIS Esophagectomy

NCT ID: NCT03140189

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-14
• Study Completion Date: 2024-04-04

Brief Summary

Minimally invasive esophagectomy (MIE) have become increasingly popular in esophageal cancer. It is generally accepted that comparing to open resections, MIE results in decreased postoperative pain, faster recovery times, and shorter hospital stays with comparable oncologic outcomes. However, MIE poses an important challenge for established thoracic surgeons as it is a difficult technique to become skilled at with an protracted learning curve. Standard laparoscopic and thoracoscopic instruments are rigid and provide a finite freedom of movement with a two dimensional visualization of the operating field. Such a difficulty is increased even more when the Ivor-Lewis esophagectomy with an intrathoracic anastomosis is needed.

Robot- assisted surgical system has opened a new era of minimally invasive surgery. Robot- assisted surgery offers some advantages including high- definition three- dimensional visualization and 7 degrees of freedom with the use of its surgical wrists, motion scaling, and tremor filtration, allowing the surgeon to perform complex operations comfortably in the domain of urinary tract, hepatobiliary and gynecological surgery. Although a robot-assisted thoraco- laparoscopic minimally invasive esophagectomy (RAMIE) was initiated from 2003, the published experience with RAMIE remains small, especially for Ivor- Lewis approaches. The aim of this study was to investigate the short- term and long-term outcomes of RAILE to identify any clinical or oncologic benefits of RAILE in esophageal cancer.

Detailed Description

This confirmatory, nonrandomized, single-arm trial (phase II) will be conducted to evaluate short-and long-term outcomes of robot-assisted thoraco- laparoscopic minimally invasive esophagectomy for esophageal cancer. Patients will registered preoperatively. The planned sample size was 51. Preoperative endoscopic biopsy was performed in all patients to confirm the histological diagnosis of esophageal cancer. Staging workup included thorough history and physical examination, esophagogastroduodenoscopy, endoscopic ultrasonography, and integrated positron emission tomography/computed tomography scan. Patients with histologically proven malignancy were candidates for surgical procedures. Operability criteria were defined according to the National Comprehensive Cancer Network guidelines. All patients were within the American Society of Anesthesiologists (ASA) class I to III. In general, neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease. The primary endpoint in the first stage is the short-term postoperative complications, and that in the second stage is overall survival; patients continue to be followed up for this endpoint.

Conditions

Clinical or Oncologic Benefits of Robot-assisted IVOR-LEWIS in Esophageal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Patients with histologically proven esophageal malignancy

2. All patients were within the American Society of Anesthesiologists (ASA) class I to III

3. neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease

Exclusion Criteria

Cancer located at the cervical esophageal Cancer located at the gastroesophageal junction history of surgery in the right thorax

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hecheng Li M.D., Ph.D

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yajie Zhang

Shanghai, , China

Countries

China

References

Wee JO, Bravo-Iniguez CE, Jaklitsch MT. Early Experience of Robot-Assisted Esophagectomy With Circular End-to-End Stapled Anastomosis. Ann Thorac Surg. 2016 Jul;102(1):253-9. doi: 10.1016/j.athoracsur.2016.02.050. Epub 2016 May 4.

Reference Type: BACKGROUND

PMID: 27154153 (View on PubMed)

Park S, Hwang Y, Lee HJ, Park IK, Kim YT, Kang CH. Comparison of robot-assisted esophagectomy and thoracoscopic esophagectomy in esophageal squamous cell carcinoma. J Thorac Dis. 2016 Oct;8(10):2853-2861. doi: 10.21037/jtd.2016.10.39.

Reference Type: BACKGROUND

PMID: 27867561 (View on PubMed)

Other Identifiers

RTS-003

Identifier Type: -

Identifier Source: org_study_id